Tag Archives: Randomized Clinical Trials

A Fight Against Providing Informed Consent in SUPPORT- Part II Randomized Clinical Trials

There have been a number of articles written by well-known physicians and bioethicists expressing great concern over the recent Office for Human Research Protection, OHRP, letter of criticism with respect to the SUPPORT clinical trial. This blog discussed this controversy in the post of May 23, 2013. This controversy has turned dark with efforts to intimidate the OHRP.. Not attractive in the arena of customarily well reasoned debates in the bioethics community. The latest in this saga is a plea signed off on by, as they describe themselves, a group of scholars and leaders in bioethics that was published in…

A Fight Against Providing Informed Consent and The Risk of Randomization in the SUPPORT Clinical Trial Randomized Clinical Trials

A Fight Against Providing Informed Consent and The Risk of Randomization: Informed Consent in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT)  by Bernard W. Freedman,JD, MPH     In their article Risk, Consent, and SUPPORT  David Magnus and Arthur Caplan chastise the Office for Human Research Protections (OHRP) for their findings of a failure to provide adequate informed consent as required by federal regulations, in a clinical trial.  The OHRP is right in their position. The underlying clinical trial, Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), published in 2010, sought to evaluate the effects of different levels of…

Mandated Insurance Coverage for Phase I and II Clinical Trials Clinical Bioethics

At present the Missouri State Senate is considering new legislation (SB 365), which means to provide health insurance coverage for Phase I and Phase II clinical trials for cancer treatment. The law in the state of Missouri presently limits mandated insurance coverage to Phase III and Phase IV clinical trials. Aside from the fact that this bill makes no sense whatsoever, it highlights the ignorance of what Phase I or Phase II trials are intended to accomplish. SB 365 seeks to force insurers, non profit health services plans, or health maintenance organizations to treat Phase I and II trials as if…

Randomized Pediatric Clinical Drug Trials – Africa and America Articles

In 1996, Pfizer needed a randomized trial for a new broad spectrum antibiotic and sent a team of its doctors into the Nigerian slum City of Kano during a meningitis epidemic. It was represented, to be a "humanitarian mission.” A team of Pfizer doctors arrived at the Nigerian camp where meningitis had killed at least 11,000 people.  They set up near a medical station run by Doctors Without Borders who were providing standard treatment. At the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were…